# K191596: Arcadia Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Oct 9, 2019 after 114 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K981251 (1998). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123771: Kyphon Express II Inflatable Bone Tamps, Medtronic (2012) Summary page 4.
- K141930: Osseoflex SB, 10G/4ML, Osseoflex SB, 10G/2ML, Osseon, LLC (2014) Summary page 4.

## Indications for use
The Arcadia ™ Steerable and Straight Balloon Catheters are intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. These balloon catheters are to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement for use during percutaneous vertebral augmentation, such as kyphoplasty.

Source page: https://510kreport.com/device/K191596
Methodology: https://510kreport.com/methodology